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Measurement of Endothelial Function and Cardiac Output: New Methods

Completed
Conditions
Hypertension
Hypertension, Pulmonary
Heart Failure
Diabetic Nephropathies
Registration Number
NCT02299960
Lead Sponsor
Charite University, Berlin, Germany
Brief Summary

The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
101
Inclusion Criteria
  • Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
  • Signed consent form

HFpEF:

  • Baseline-Echocardiography:
  • hospitalization <= 12 months with diagnosis heart failure and E/E' > 8 or E' < 8 cm/s or
  • BNP >= 100pg/ml or NT-proBNP >= 300pg/ml in the last 6 months or
  • LAVI > 28 ml/m² and E/E' > 8 or E' < 8cm/s or PAPsys > 40mmHg and E/E' > 8 or E' < 8 cm/s
  • Possibility to take part in cardiac stress test
  • Heart failure NYHA I-III
  • Sinus rhythm
  • Max. O2-uptake on exertion < 20ml/kgBW/min

HFrEF

  • HFrEF due to ischemic or non-ischemic reasons
  • NYHA I-III
  • Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)
  • EF <=45%, Simpson Biplan PH
  • NICE-Classification 2013 I/II
  • PAH >= 25 mmHg
  • Precapillary PAH: Wedge-pressure <= 15 mmHg, CO normal or low
  • Postcapillary PAH: Wedge-pressure >= 15 mmHg, CO normal or low

Diabetic nephropathy:

  • Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
  • Diabetic nephropathy has been diagnosed before (anamnesis)
  • Macroalbuminuria: Urine Albumine/Creatinine-ratio > 300mg/g Creatinine (>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR <90ml/min/1.73m² (CKD-EPI)
  • Microalbuminuria: 30-300mg/g Creatinine (>=3.4 mg/mmol but <34mg/mmol) tested as above and GFR < 90 ml/min/1.73m² and diabetic retinopathy

AH:

  • Hypertension diagnosed at least 6 months except structural heart disease: EF > 55% and no sign of HFpEF
  • No symptoms of coronary heart disease
  • Possibility to take part in cardiac stress test
  • Stable pharmacologic therapy of Hypertension for at least 4 weeks
  • Systolic blood pressure <140 mmHG during Screening
Exclusion Criteria
  • Patient incapable of contracting
  • Angina pectoris > CCS II
  • Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
  • Myocardial infarction in the last 3 months
  • Stroke in the last 3 months
  • Valvular heart disease > II°
  • Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
  • Congenital complex heart disease
  • Active myocarditis
  • Significant lung disease
  • Significant Cardiac dysrhythmia
  • Scheduled changes in medication during time of study
  • (Scheduled) heart transplant
  • Cardiac resynchronisation therapy over the last three months
  • ICD/Pacemaker-implant in the last 4 weeks
  • Uncontrolled Hyper/Hypotension (>180mmHg, <95mmHg)
  • Patient taking part in Rehabilitation program
  • Diagnosed Malignant disease or disease with life expectancy < 1 year
  • Anemia with Hb<10mg/dl
  • Untreated significant thyroid disease

HFpEF, Hypertension and PH:

  • Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
  • Significant changes in cardiovascular Status over the two weeks of study
  • Instable cardiopulmonary Status over the last four weeks

HFrEF:

  • I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
  • Myocardial infarction in the last 4 weeks

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Test-retest-reliability EndoPAT2 weeks
Secondary Outcome Measures
NameTimeMethod
Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test2 weeks
Correlation cardiac Output on exertion and echocardiography in HFpEF2 weeks
Clinical feasibility of circulating endothelial cells and EndoPAT2 weeks
Test-retest-reliability circulating endothelial cells2 weeks
Correlation: circulating endothelial cells and EndoPAT and endothelial function2 weeks

will include the molecular diagnostic of circulating endothelial cells

Test-retest-reliability NICOM2 weeks
Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome2 weeks

Trial Locations

Locations (1)

Charite Universitaetsmedizin

🇩🇪

Berlin, Germany

Charite Universitaetsmedizin
🇩🇪Berlin, Germany

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